CompletedPhase 4

Dexmedetomidine vs Midazolam for Intraoperative Sedation

Brazil120 participantsStarted 2016-01

Plain-language summary

This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia. The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications. Secondary objectives included the determination of superiority regarding the postoperative period. For that, patients were randomized into two groups and sedated with either Midazolam or Dexmedetomidine.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Undergoing surgery under regional anesthesia Exclusion Criteria: * The presence of any Bradyarrhythmia; * New York Heart Association (NYHA) Functional Classes III and IV Heart Failure and/or Left Ventricle Ejection Fraction under 30%; * Respiratory Failure, Glasgow Coma Scale score 8 or under, and Liver Failure - due to the increased risk of sedation in patients with these conditions (d) refusal to participate in the study or withdrawal of consent at any moment.

What they're measuring

Depth of Sedation

Timeframe: Intraoperative

Respiratory depression

Timeframe: Intraoperative

Bradycardia

Timeframe: Intraoperative

Hypotension

Timeframe: Intraoperative

Trial details

NCT IDNCT02878837

SponsorInstituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04

View on ClinicalTrials.gov More Failed Moderate Sedation During Procedure trials